Compatibility study between ibuprofen and excipients in their physical mixtures

• Published in: Journal of thermal analysis and calorimetry 2011-08, Vol.105 (2), p.517-527
• Main Authors: Tiţa, Bogdan, Fuliaş, Adriana, Szabadai, Zoltan, Rusu, Gerlinde, Bandur, Geza, Tiţa, Dumitru
• Format: Article
• Language: English
• Subjects: Analytical Chemistry; Biological and medical sciences; Calorimetry; Cellulose; Chemistry; Chemistry and Materials Science; Derivatives; Differential scanning calorimetry; Diffraction; Excipients; General pharmacology; Hostages; Ibuprofen; Inorganic Chemistry; Lactose; Magnesium compounds; Measurement Science and Instrumentation; Medical sciences; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Physical Chemistry; Polymer Sciences; Thermal properties; Thermogravimetry; X-rays
• ISSN: 1388-6150; 1588-2926; 1572-8943
• DOI: 10.1007/s10973-010-1188-8

The thermal techniques of analysis were used to assess the compatibility between ibuprofen (IB) and some excipients used in the development of extended released formulations. This study is a part of a systematic study undertaken to find and optimizes a general method of detecting the drug–excipient interactions, with the aim of predicting rapidly and assuring the long-term stability of pharmaceutical product and speeding up its marketing. The thermal properties of IB and its physical association as binary mixtures with some common excipients were evaluated by thermogravimetry/derivative thermogravimetry (TG/DTG) and differential scanning calorimetry. FT-IR spectroscopy and X-ray powder diffraction (XRPD) were used as complementary techniques to adequately implement and assist in interpretation of the thermal results. Based on their frequent use in preformulations nine different excipients: starch; microcrystalline cellulose (PH 101 and PH 102); colloidal silicon dioxide; lactose (monohydrate and anhydre); polyvinylpyrrolidone; magnesium stearate and talc were blended with IB. The samples were prepared by mixing the analyte and excipients in a proportion of 1:1 (w:w). The TG/DSC curves of the IB have shown a single stage of mass loss between 175 and 290 °C, respectively, an endothermic peak at 78.5 °C, which corresponds to the melting (literature T m  = 75–78 °C).